Postoperative analgesic efficacy and safety of imrecoxib versus celecoxib in hip osteoarthritis patients undergoing total hip arthroplasty: a multi-center, randomized, controlled, non-inferiority study.

Background: Imrecoxib, a novel cyclooxygenase-2 inhibitor, possesses a certain postoperative analgesic effect for several orthopedic surgeries. This multi-center, randomized, controlled, non-inferiority study intended to investigate the postoperative analgesic efficacy and safety profile of imrecoxib (versus celecoxib) in hip osteoarthritis patients undergoing total hip arthroplasty (THA).

Methods: 156 hip osteoarthritis patients planned for THA were randomized into imrecoxib (N = 78) and celecoxib (N = 78) groups. Patients were orally administrated with imrecoxib or celecoxib 200 mg at 2 h (h) after THA, 200 mg every 12 h to day (D)3, and 200 mg every 24 h to D7; additionally, each patient received patient-controlled analgesia (PCA) for 2 days.

Results: Resting pain visual analogue scale (VAS) score at 6 h, 12 h, D1, D2, D3, and D7 post THA was not varied between imrecoxib and celecoxib groups (all P > 0.050), neither was moving pain VAS score (all P > 0.050). Importantly, the upper of 95% confidence interval of pain VAS score margin between imrecoxib and celecoxib groups was within the non-inferiority threshold (Δ = 1.0), indicating the fact that non-inferiority was established. The additional and total consumption of PCA was not varied between imrecoxib and celecoxib groups (both P > 0.050). Also, no difference was seen in Harris hip score, European Quality of Life 5-Dimensions (EQ-5D) total and VAS scores at month (M)1, M3 between the two groups (all P > 0.050). Besides, the incidences of all adverse events were not different between imrecoxib and celecoxib groups (all P > 0.050).

Conclusion: Imrecoxib is non-inferior to celecoxib for postoperative analgesia in hip osteoarthritis patients undergoing THA.